Pumped up

June 3, 2009 by Alison Carter

Omnipod_300x200.jpg [1]

The symptoms had started about three weeks before — feeling constantly tired and thirsty, going to the bathroom frequently and losing a drastic amount of weight.

My doctor told my parents to bring me to the Children's Hospital of Philadelphia [2], where I would learn how to adjust my diet and schedule, administer medication and deal with the illness.

I had one roommate during my four-day stay at the hospital. She was tall and thin with dark skin and big, brown eyes, a sweet girl. When we were learning to inject insulin for the first time, she just could not do it and she started crying uncontrollably. I took brief glances at her side of the room and watched as her parents tried calming her down. I never enjoyed getting shots for vaccinations growing up, but I never resisted. When it came time to take a shot of insulin, I never had my parents inject me; I always administered the insulin myself.

That was seven years ago. I'm 19 and leading a remarkably normal life. Most people have no idea I have the disease — until mealtime, when I pull out a syringe and have to explain that I'm not a heroin addict. I just have Type 1 diabetes.

Pumps and pods

Though I've never sacrificed my ambitions because of the disease, living with it can be troublesome. There just aren't many options available to Type 1 diabetics. There's the system I'm on, which involves injecting a combination of two types of human insulin (long-term Humilin N and short-term Humolog) three times a day. Another system, the Lantus [3] method, involves injecting a large dose of Lantus insulin before bedtime and a small dose of short-term human insulin before each meal.

Insulin pumps can significantly improve blood sugar management and allow for greater flexibility in diet and schedule. But of the estimated 171 million diabetics worldwide, only about 15 percent are pump-users. What prevents more people from using the pump?

That's the question Type 1 diabetic Rob Campbell asked eight years ago, after his physician at Boston's Joslin Diabetes Center introduced him to John Garibotto, one of the eventual founders of Insulet Corp. [4]

"We really wanted to understand why there were so few people on them even though they were touted as the best therapy," says Campbell, Insulet's vice president of clinical services and research.

The typical insulin pump is a small, battery-operated, computer-powered device that mimics the function of a healthy pancreas. The device is pre-programmed to deliver insulin continuously over 24 hours (basal rates) and according to carbohydrate intake during meals (bolus dosages). Typically, the insulin is pumped through an infusion line fitted with a tiny plastic tube called a cannula that's inserted just under the skin on the stomach and taped in place. The infusion set is changed every few days.

After talking to thousands of patients, doctors, educators and insurance providers and a round of market research, Campbell identified four fundamental insulin pump features that concern today's diabetics: Safety and reliability, ease of use, discretion and affordability.

"Insulin pumps in general have not changed in over thirty years," Campbell says. "We needed to remove the technicalities and complexities in order to meet patient's needs and tap into the market."

Meet the OmniPod Insulin Management System, Insulet's two-part continuous insulin delivery system. It consists of the OmniPod itself, a small, round insulin reservoir that holds up to 200 units of insulin (about three days' worth); and a wireless Personal Diabetes Manager that communicates with the OmniPod to initiate priming and cannula insertion and administer basal rates and bolus dosages according to programmable settings, while also incorporating a FreeStyle [5] blood glucose meter.

"Our product integrates all the functionality of conventional pumps into one small, wearable device," Campbell explains. "One, we have no tubing. Two, there's no need for manual insertion of the cannula. Three, it's discreet and easy to use."

And the device has the lowest start-up cost compared with its competitors. The One Touch Ping [6] from Animas costs about $7,000; MiniMed's Paradigm 522 [7] costs about $6,000. Not every insurance plan covers all or even most of these costs.

"If an insurance company will only pay 50 percent of the costs of a pump, that would leave the patient paying perhaps half of the $8,000 cost of the pump, plus perhaps half of the $300 to $400 cost of monthly supplies," notes Christina Preis [8], an endocrinologist at the Diabetes Center for Children [9].

For most people, that's a huge of out-of-pocket expense. For diabetics in the developing world, it's out of the question.

The OmniPod starter kit has a list price of $950. A month's supply of insulin pods costs $365.

Insulet makes its move

The Food & Drug Administration [10] cleared the OmniPod for sale in January 2005. Since its national rollout during the second quarter of 2008, the company's consumer base has grown to over 10,000 patients.

But Insulet has even grander ambitions. The diabetes therapy market is one of the largest sectors in the global healthcare industry, valued at more than $21 billion in 2006 and more than $25 billion a year later, according to Visiongain [11]. The market is likely to top $26.3 billion in 2009 and grow to $34.5 billion by 2013, Espicom Business Intelligence Ltd. [12] forecasts.

The European Union [13] gave the OmniPod its CE Mark April 28, granting Insulet the right to distribute the device throughout the European Union and in other countries that recognize the mark.

Type 1 and Type 2 diabetes are the main markets for the device, but it can also be used to treat gestational diabetes. During pregnancy, some women require strict blood glucose control for a three-month period, something the OmniPod can be used to regulate. The in-hospital market is a tertiary market; hospitals can integrate the device in heart procedures, steroid administration and in the treatment of trauma.

Pumps vs. traditional therapies

For many Type 2 patients, howver, insulin pump therapy isn't necessary.

"Insulin pumps are useful for patients who have complex insulin regiments that would otherwise need multiple daily injections," according to Dr. James Rosenzweig, director of diabetes services at Boston Medical Center [14]. Type 2 patients are generally treated with diet, exercise and oral medication, in addition at most a single daily injection, Rosenzweig explains.

So it makes sense that so few diabetics use the pump. Type 1 patients make up only about 10 percent of the total population of people with diabetes.

And insulin pump therapy doesn't work for everyone, either.

"Putting the majority of people on insulin pumps won't solve the problem of diabetes control," says Rosenzweig.

The Diabetes Control and Complications Trial [15], a breakthrough clinical study conducted from 1983 to 1993, showed that keeping blood glucose counts within a healthy range through intensive therapy slows the onset and progression of the eye, kidney and nerve diseases caused by diabetes.

Patients were randomly assigned to intensive therapy administered either with the pump or by three or more daily insulin injections and guided by frequent blood glucose monitoring or to conventional therapy with one or two daily insulin injections.

Patients in the intensive therapy group, whether they used the pump or administered multiple daily injections, achieved the same results.

As this study demonstrates, a person doesn't have to be on the pump to achieve good control. Some people do well on the pump; others do better on injections. The main factor for determining the best treatment for diabetes is individual character.

"[The pump] requires a lot of intense effort and behavioral compliance," Rosenzweig explains. "It's useful to patients who are motivated and want to improve their control."

"The pump is only as good as the person willing or able to tell it what to do," adds Pries.

A patient's experience

Paul Guglielmino, a 32-year-old Type 1 diabetic, has used the OmniPod since December 2008. He was diagnosed with diabetes at age 10 and was initially treated with a daily injection of Humilin N.

"It wasn't until my second year of college that I started going to the Joslin Diabetes Center [16] and speaking to the doctors there," Guglielmino says. "I was getting things more under control at that point. They definitely suggested moving to Humolog and eventually I went up to three injections a day."

His physician at Joslin suggested moving to insulin pump therapy and introduced him to different brands. After reviewing various options and talking to their users, Guglielmino decided to go with the OmniPod.

"The wireless was the big win," he recalls.

Since he started using the device, his blood glucose readings have improved, with a significant decrease in low blood sugars. But adjusting to the OmniPod hasn't been easy.

"In the beginning, I had a lot of trouble with pods not working," Guglielmino explains. "I don't know if it was my inexperience, or maybe they really weren't working, so I went through a lot of them."

"One time, the tube didn't insert into my skin. The cannula missed; it was laying on the skin. I've had another issue with the tubing falling out in the middle of the night."

The OmniPod appears to have a lower infusion success rate than other pumps that require manual cannula insertion.

Despite the initial malfunctions, Guglielmino says he'd never use anything else.

"Overall, I've definitely been happy," he says. "It's a good product and it's just going to get better."

Still, he has a few suggestions for improvements: Make the device's profile lower to the body, make the PDM smaller, establish a recycling program for used pods and integrate continuous glucose monitoring technology.

The next generation OmniPod

Asked about Guglielmino's suggestions, Campbell says the company is actively developing the OmniPod 2.0, noting that "we have publicly announced relationships with Abbot Diabetes Care [17] and Dexcom [18]," two major medical device companies that offer continuous glucose monitoring technology.

Increased demand for the OmniPod, along with a $60 million funding commitment from healthcare investor Deerfield Management [19], means the company can focus on improving its product.

"We are here to stay," says Campbell. "We are passionate about making sure that people around the world get access to this new and innovative product to better manage their diabetes."

Permalink [21]